Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390
NCT ID: NCT00996216
Last Updated: 2013-12-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
27 participants
INTERVENTIONAL
2009-09-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label eltrombopag
Open-label eltrombopag with dose titrations to support adequate platelet counts.
Eltrombopag
Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.
Antiviral therapy
Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.
Interventions
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Eltrombopag
Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.
Antiviral therapy
Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female ≥18 years old
* Evidence of chronic HCV infection
* While participating in TPL103922 or TPL108390, discontinued from study drug due to thrombocytopenia
* Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin
* Platelet count \<75,000
* Fertile males and females must use two forms of effective contraception during treatment and for 24 weeks after treatment
* Ability to understand and comply with the protocol requirements and instructions
* Ability to provide written informed consent
Exclusion Criteria
* Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag, or their ingredients
* History of clinically significant bleeding from oesophageal or gastric varices
* History of arterial or venous thrombosis and two or more of the following risk factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic contraception (containing estrogen); smoking; diabetes; hypercholesterolemia; medication for hypertension or cancer
* Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
* Evidence of hepatocellular carcinoma
* HIV or Hepatitis B infection
* Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to eltrombopag therapy
* Malignancy diagnosed or treated within the past five years. Except for localized basal or squamous cell carcinoma treated by local excision or malignancies that were adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival.
* Pregnant or nursing women
* Men with a female partner who is pregnant
* History of alcohol/drug abuse or dependence within six months of the study start unless participating in a controlled rehabilitation programme.
* Treatment with an investigational drug or interferon within 30 days or 5 half-lives (whichever is longer) of the screening visit
* History or platelet clumping that prevents reliable measurement of platelet counts
* Evidence of portal vein thrombosis within three months of baseline visit
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
New Haven, Connecticut, United States
GSK Investigational Site
Honolulu, Hawaii, United States
GSK Investigational Site
Manhasset, New York, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Camperdown, New South Wales, Australia
GSK Investigational Site
Randwick, New South Wales, Australia
GSK Investigational Site
Herston, Queensland, Australia
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Nice, , France
GSK Investigational Site
Pessac, , France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Bologna, Emilia-Romagna, Italy
GSK Investigational Site
Genoa, Liguria, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Lahore, , Pakistan
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Pontevedra, , Spain
GSK Investigational Site
Valencia, , Spain
Countries
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Other Identifiers
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108392
Identifier Type: -
Identifier Source: org_study_id